Clearance Summary
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE received FDA 510(k) clearance under submission number K093861, sponsored by Iris International, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2010-02-05.
- Submission: K093861
- Applicant / Sponsor: Iris International, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5200
- Decision date: 2010-02-05
Classification & Regulation
This clearance is catalogued under FDA product code LKM and 21 CFR 864.5200, within the Hematology review panel as a Class II device.